There are many patients affected with disease or other physiological conditions that for one reason or another are unable to receive nutrition normally through the mouth which is then swallowed and broken down and absorbed by the digestive system. People suffering from stroke, Alzheimer's disease, cancer, inflammation or other infirmities, often cannot properly chew or swallow their food or medication which must then be delivered to the patient in another fashion if starvation and malnutrition are to be avoided.
Gastroenterologic feeding tubes have been known for years and are inserted into the stomach by any one of a number of different methods. Generally, a catheter is placed in the body by way of the mouth and using suture thread, is pulled downward into the stomach and either left there or is pushed further down into the jejunum of the small intestine. The feeding tubes may also enter the body either by way of the nasal passageway or by means of a gastrostomy.
In a gastrostomy, a surgical procedure is performed on the abdomen wherein the opening is cut through the skin, facia and stomach wall. A tube is inserted through the opening so as to allow food to be provided directly to the stomach or intestines.
Recently, percutaneous endoscopic gastrostomy (PEG) was developed which makes placement of the enteral feeding tube within the stomach or small intestine a great deal easier. Here, an endoscope is used to visualize the desired insertion site on the gastric mucosa and the subsequent creation of a surgical opening into the stomach through the abdominal wall. The percutaneous endoscopic techniques used to place enteral feeding tubes within the patient are generally carried out in one of three ways.
In a conventional "pull" procedure, an endoscope is inserted through the esophagus of the patient, and the stomach is then inflated. Using the endoscope to locate an appropriate site in the stomach wall, a cannula or needle is then inserted through the stomach wall, and a string inserted through the needle. The needle may then be removed. The string is grasped by means of a snare passing through the endoscope, and the endoscope and snare are pulled up through the esophagus, such that one end of the string comes out through the mouth, leaving the other end protruding through the opening made by the needle. A gastrostomy catheter is then tied to the end of the string which protrudes from the mouth, conventionally by means of another string attached at one end of the gastrostomy catheter.
The catheter is then pulled down into the stomach by pulling on the end of the string which protrudes through the opening in the stomach and the catheter is pulled through the opening as well. The catheter is usually provided with a tapered dilator at the leading end to assist in passing through the stomach wall. The catheter is held in place by a retention means against the interior of the abdominal wall. Another retention means is placed on the exterior, so as to hold the catheter in place against the stomach. The endoscope is reinserted to ensure proper placement of the catheter.
In the technique set forth by Russell, sometimes referred to as the "push" technique, a needle is first inserted into the stomach (at a site located by endoscopy, as with the pull procedure), and then a guide wire is inserted through a lumen in the needle. A small incision is then made in the fascia next to the guide wire, after which an interiorly lubricated sheath having a splittable seam is guided, along with a tapered dilator, over the guide wire and into the stomach. Once the sheath is in place, the dilator and guide wire are removed, and a balloon catheter is inserted through the lubricated central lumen of the sheath. A distal balloon of the catheter is then inflated and the sheath is peeled or split away along its seam or seams, thus leaving the catheter emplaced in the stomach. Sutures are provided to maintain tension of the balloon against the peritoneum.
When the enteral feeding tubes are to be placed in the jejunum or small intestine, generally some additional steps are required. After the enteral feeding tube has been placed through the ostomy and into the stomach, the loop of the suture aids in the proper positioning of the distal end of the feeding tube within portions of the gastrointestinal tract beyond the pylorus valve. Generally, the loop is grasped by endoscopic forceps. By manipulation of the forceps, the loop and the distal end of the enteral feeding tube are properly positioned within either the duodenum or the jejunum.
There are, however, certain drawbacks to this prior art, loop-containing attachment. First, the suture is intended to lead and extend in a forward direction from the distal end of the enteral feeding tube. The suture is, however, made of a non-rigid fabric. For this reason, as the enteral feeding tube is inserted through the PEG tube, or cannula within the ostomy, the suture has a tendency to trail the feeding tube. This tendency causes the suture to become reversed, and to "double-over" the sides of the feeding tube. The suture thus becomes lodged between the enteral feeding tube and the PEG tube, this "doubling over" of the suture inhibits the free movement of the enteral feeding tube through the PEG tube.
Yet another problem arises when the feeding tube has been inserted within the body of the patient. As discussed above, the loop of the suture is grasped by a pair of endoscopic forceps. As it is moved through the body, the suture loop tends to become wetted by and absorbs various body fluids. When the enteral feeding tube is properly positioned within the duodenum or jejunum and the endoscopic forceps are opened to release the wetted suture, that suture may nevertheless stick to the forceps. As a result, the suture and the enteral feeding tube to which it is attached may follow the forceps while the forceps are being withdrawn from the body cavity. In this manner, the enteral feeding tube may be moved from its intended position.
In a third technique which essentially is a surgical one, the tip of the enteral feeding tube is placed in the stomach and is grasped by a forceps or wire loop. In this manner, the tip of the tube is manipulated surgically through the ostomy and is directed from the stomach through the pylorus and into a position within the jejunum which comprises the upper third of the small intestine. However, since the feeding portion of the tube is of relatively small diameter and made of smooth plastic, there is often a great deal of difficulty encountered in grasping, moving, directing and holding the tip of the feeding tube while it is within the lubricous and slippery walls of the gastrointestinal environment. It would therefore be advantageous to provide a means that allows for a better hold of the tube without providing additional objectionable protrusions that might irritate, damage or tear the soft mucosal linings of the esophagus, stomach and small intestine during gastrointestinal implantation.
U.S. Pat. No. 5,098,378 to Piontek et al. discloses and claims a replacement gastrostomy tube for jejunal feeding in which an expandable component of the tube is located at the distal end thereof. Fluid is passed through a fluid flow channel which enters the expandable component and inflates it like a balloon. In this fashion, the balloon and an adjacent retention device are pressed against the wall of the stomach, securing the feeding tube in the stoma.
U.S. Pat. No. 5,152,756 to Quinn et al. discloses an improved enteral feeding tube in which a bulbous extension member is attached to the distal end of the feeding tube. The extension is comprised of a stem portion that projects beyond the end of the tube parallel to the axis of the tube and forms a large spherical tip at its end. In this manner, the stem extension can be more easily grasped by forceps for surgical placement.
U.S. Pat. No. 5,100,384 to McBrian et al. discloses a device for percutaneous intubation in which the feeding tube comprises an inflatable lumen that expands as a water swellable foam material contained therein absorbs water from the gastrointestinal cavity after intubation. A wire or suture loop is disposed at the terminal end of the feeding tube lumen for attachment to a wire used in pulling the tube through the esophagus and stomach during the intubation procedure.
U.S. Pat. No. 5,037,387 also to Quinn et al. discloses a method for positioning an enteral feeding tube within a patient's body and a tube for use therein comprising a flexible polyurethane tube and a rigid stem portion at the distal end thereof that forms an outlet from which the nutritional fluid flows. The stem itself ends in a spherical tip or ring which prevents the possibility of a puncture of the gastrointestinal tract as the enteral feeding tube is pulled.
None of these prior art gastrostomy tubes provide an easy and effective means to enable the surgeon to quickly and safely place the tube within the jejunum. Moreover, none of the prior art methods or devices allow the surgeon to safely locate and grasp the distal end of the feeding tube without posing a risk of injury to the organ walls and fascia. Nothing suggests a means whereby despite the slippery and lubricous environment of the gastrointestinal tract, the tube can be firmly grasped and directed into the jejunum without the risk of getting caught or lodged within the pyloric valve or duodenum.